MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRACHEOSTOMY/PVC PORTEX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/563/080

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Udi information is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A review of the manufacturing process was conducted by quality engineer (qe) in order to verify that there are no situations or practices that could create the event.The cuff assembly operation was reviewed; no discrepancies were found.Inflation line assembly operation was reviewed; no discrepancies were found.A product sample was received for evaluation.Visual inspection and function tests was performed.The returned sample was received in used condition without its original packaging.The sample for this complaint was sent to the manufacturing site, who carried out a full investigation into the reported issue based on the sample which returned.Original equipment manufacturer (oem) evaluated the returned device for further analysis and upon visual inspection observed one tear in the cuff.Inflation test was audited during thirty-two (32) units, in order to verify that the inflation test was properly performed; the inflation test was performed according to the test method stated in the manufacturing procedure; no deflated cuffs were detected during the thirty-two (32) units tested.The root cause was unable to be undetermined.Actions taken to mitigate the reported issue: no further actions required as the investigation shows the trend of cuff leakages declining after corrections actions were performed.

Event Description

It was reported that upon checking the product prior to insertion, it was noted that the cuff would not inflate.Another product was used.No patient injury was reported.

• Brand Name: TRACHEOSTOMY/PVC PORTEX
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15599329
• MDR Text Key: 306331240
• Report Number: 3012307300-2022-23889
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/563/080
• Device Lot Number: 3533641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1